SEC · Class II · 21 CFR 890.3780

FDA Product Code SEC: Wearable Fall Injury Prevention Device

A Wearable Fall Injury Prevention Device Is Intended To Detect Falls And Prevent Major Fall Injuries. Once A Fall Is Detected, The Device Deploys A Protective Mechanism To Reduce The Risk Of Injury.

Leading manufacturers include Active Protective Technologies, Inc..

1
Total
0
Cleared
328d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Wearable Fall Injury Prevention Device Devices (Product Code SEC)

1 devices
1–1 of 1
Not Cleared Apr 09, 2025
Tango® Belt (Model SAS-001-01 (XS)
DEN240021
Active Protective Technologies, Inc.
Physical Medicine · 328d

About Product Code SEC - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SEC since 2025, with 0 receiving FDA clearance (average review time: 328 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SEC devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →